Real-world short-term effectiveness of ustekinumab in 305 patients with Crohn's disease: results from the ENEIDA registry
Por:
Iborra, M, Beltran, B, Fernandez-Clotet, A, Gutierrez, A, Antolin, B, Huguet, J, De Francisco, R, Merino, O, Carpio, D, Garcia-Lopez, S, Mesonero, F, Navarro, P, Ferreiro-Iglesias, R, Carbajo, A, Rivero, M, Gisbert, J, Pinero-Perez, M, Monfort, D, Bujanda, L, Garcia-Sepulcre, M, Martin-Cardona, A, Canete, F, Taxonera, C, Domenech, E, Nos, P, Sierra-Ausin, M, Ferrer-Rosique, J, Martin-Arranz, M, Gonzalez-Munoza, C, Mancenido, N, Rodriguez-Lago, I, Benitez, J, Fores-Bosch, A, Navarro-Llavat, M, Calafat, M, Madrigal-Dominguez, R, Ramos, L, Arroyo, M, Busquets, D, Lorente, R, Sainz-Arnau, E, Hernandez-Camba, A, Morales-Alvarado, V, Paredes, J, Van Domselaar, M, Hervas, D, Canada-Martinez, A, Castro-Poceiro, J, Cameo-Lorenzo, J, Fernandez-Salazar, L, Riestra, S, Casas-Deza, D, Tosca, J, Barrio, J, Garcia, M and Chaparro, M
Publicada:
1 ago 2019
Resumen:
Background There are limited data of ustekinumab administered according to the doses recommended in the UNITI studies. Aim To assess the real-world, short-term effectiveness of ustekinumab in refractory Crohn's disease (CD) Methods Multicentre study of CD patients starting ustekinumab after June 2017 at the recommend dose (260, 390 or 520 mg based on weight ~6 mg/kg IV week 0 and 90 mg subcutaneously week 8). Values for Harvey-Bradshaw Index (HBI), C-reactive protein (CRP) and faecal calprotectin (FC) were recorded at baseline and at weeks 8 and 14. Demographic and clinical data, previous treatments, AEs and hospitalisations were documented. Possible predictors of clinical remission were examined. Results Three hundred and five patients were analysed (>= 2 previous anti-TNF alpha therapies 64% and vedolizumab 29%). At baseline, 217 (72%) had an HBI >4 points. Of these, 101 (47%) and 126 (58%) achieved clinical remission at weeks 8 and 14, respectively. FC levels returned to normal (<250 mu g/g) in 46% and 54% of the patients at weeks 8 and 14 respectively. CRP returned to normal (<3 mg/L) in the 35% and 41% of the patients at week 8 and 14 respectively. AEs were recorded in 38, and 40 patients were hospitalised. Intolerance to the most recent anti-TNF agent and fewer previous anti-TNF agents were associated with clinical remission at week 14. Endoscopic severity was associated with poor response. Conclusion This is the first study to show the real-world effectiveness and safety of ustekinumab administered according to the recommended induction regimen in a cohort of highly refractory CD patients.
Filiaciones:
Sierra-Ausin, M:
Univ Hosp Leon, Dept Neurophysiol, Leon, Spain
Ferrer-Rosique, J:
Fdn Alcorcon Univ Hosp, Madrid, Spain
Martin-Arranz, M:
La Paz Univ Hosp, Madrid, Spain
Gonzalez-Munoza, C:
Santa Creui St Pau Univ Hosp, Barcelona, Spain
Mancenido, N:
Infanta Sofia Univ Hosp, Madrid, Spain
Rodriguez-Lago, I:
Hosp Galdakao, Galdakao, Spain
Benitez, J:
Reina Sofia Univ Hosp, Inst Maimonides Invest Biomed Cordoba IMIBIC, Cordoba, Spain
:
Gen Univ Hosp Castellon, Castellon de La Plana, Spain
Navarro-Llavat, M:
St Joan Despi Moises Broggi Univ Hosp, Barcelona, Spain
Calafat, M:
Son Llatzer Univ Hosp, Palma De Mallorca, Spain
Madrigal-Dominguez, R:
Palencia Hosp Complex, Palencia, Spain
Ramos, L:
La Laguna Univ, Hosp Univ Canarias, Tenerife, Spain
Arroyo, M:
Ctr Invest Biomed Red Enfermedades Hepat & Digest, Madrid, Spain
Lozano Blesa Cent Univ Hosp, Zaragoza, Spain
Busquets, D:
Dr J Trueta Univ Hosp Girona, Girona, Spain
Lorente, R:
Gen Univ Hosp Ciudad Real, Ciudad Real, Spain
Sainz-Arnau, E:
Hosp St Joan de Deu Athaia, Barcelona, Spain
Hernandez-Camba, A:
Nuestra Sra Candelaria Univ Hosp, Santa Cruz De Tenerife, Spain
Morales-Alvarado, V:
Granollers Gen Hosp, Barcelona, Spain
:
Peset Univ Hosp Valencia, Valencia, Spain
Van Domselaar, M:
Univ Hosp Torrejon, Madrid, Spain
Hervas, D:
IISLAFE, Inst Invest Sanitaria La Fe, Stat Unit, Valencia, Spain
Canada-Martinez, A:
IISLAFE, Inst Invest Sanitaria La Fe, Stat Unit, Valencia, Spain
Castro-Poceiro, J:
Ctr Invest Biomed Red Enfermedades Hepat & Digest, Madrid, Spain
IISLAFE, Inst Invest Sanitaria La Fe, Stat Unit, Valencia, Spain
:
Univ Gen Hosp Alicante, Alicante, Spain
Fernandez-Salazar, L:
Univ Valladolid, Valladolid, Spain
Clin Hosp Valladolid, Valladolid, Spain
Riestra, S:
Cent Univ Hosp Asturias, Oviedo, Spain
Inst Invest Sanitaria Principado Asturias ISPA, Oviedo, Spain
Casas-Deza, D:
Miguel Servet Univ Hosp, Zaragoza, Spain
Tosca, J:
Univ Valencia, Univ Clin Hosp Valencia, IBD Unit, Valencia, Spain
Barrio, J:
Rio Hortega Univ Hosp, Valladolid, Spain
Garcia, M:
Univ Cantabria, Marques de Valdecilla Univ Hosp, IDIVAL, Dept Internal Med, Santander, Spain
Chaparro, M:
UAM, Inst Invest Sanitaria Princesa IIS IP, La Princesa Univ Hosp, Inst Invest Sanitaria Princesa, Madrid, Spain
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